21 CFR 886.3100 — Clip, Tantalum, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3100
Identification
An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQW | Clip, Tantalum, Ophthalmic | 2 | 3 | Implant |
Special Controls
HQW — Clip, Tantalum, Ophthalmic
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
eCFR
